Table 1.
Previously identified trials that meet the inclusion criteria for AFFIRM
| Study name & first author | Year | Country & sample size | Participants | Intervention & control | Outcomes | Commitment to participate in IPDMA |
|---|---|---|---|---|---|---|
| TIPPS* [30] Rodger |
2013 |
Canada, Multinational N = 292 |
Thrombophilia + previous high risk criteria |
Dalteparin 5000 IU to 20 wks then 10,000 IU to 36 wks vs no Dalteparin |
PE, SB, abruption, SGA <10th percentile |
Yes |
| FRUIT [20] de Vries |
2012 |
Netherlands, Multinational N = 139 |
Prior early onset PE (n = 107) and/or SGA <10th percentile (n = 94) |
Dalteparin 5000 IU + ASA vs ASA |
PE prior to 34 weeks GA |
Yes |
| HAPPY [25] Martinelli |
2012 |
Italy, Multi-center N = 135 |
Prior PE (n = 52), prior loss >15 weeks (n = 49), prior SGA <10th percentile (n = 28) or prior abruption (n = 5) |
Nadroparin 3800 IU vsno Nadroparin |
PE, Loss >15 weeks GA, SGA <10thpercentile and/or abruption |
Yes |
| NOH-PE [21] Gris |
2011 |
France, Single center N = 224 |
Prior severe PE (n = 224) |
Enoxaparin 4000 IU + ASA vs ASA |
PE, SB, abruption, SGA <5th percentile |
Yes |
| NOH-AP [24] Gris |
2010 |
France, Single center N = 160 |
Prior abruption (n = 160; 70 with PE) |
Enoxaparin 4000 IU+/−ASA vs +/−ASA |
PE, SB, abruption, SGA <5thpercentile |
Yes |
| Rey [23] |
2009 |
Canada, Multi-center N = 116 |
Prior early PE (n = 60), prior abruption (n = 16), prior SGA <5th percentile (n = 21), loss >12 weeks (n = 17) |
Dalteparin 5000 IU+/−ASA vs +/−ASA |
PE, SB, abruption, SGA <5th percentile |
Yes |
| Mello [22] | 2005 | Italy, Single center N = 80 | Prior PE with ACE DD (n = 80) | Dalteparin 5000 IU vsno Dalteparin | PE, SGA <10th percentile | Unable to contact |
ASA = aspirin; GA = gestational age; IPDMA = individual patient data meta-analysis; IPDMA = individual patient data meta-analysis; PE = pre-eclampsia; RCT = randomized controlled trial; SB = stillbirth; SGA = small-for-gestational age.
Trial Names:
TIPPS = Thrombophilia In Pregnancy Prophylaxis Study *accepted for publication in the Lancet.
FRUIT = FRactionated heparin in pregnant women with a history of Utero-placental Insufficiency and Thrombophilia.
NOH-AP = Nîmes Obstetricians and HAematologist – abruptio placentae.
NOH-PE = Nîmes Obstetricians and HAematologist - pre-eclampsia.
HAPPY = Heparin in pregnant women with Adverse Pregnancy outcome to improve the rate of successful PregnancY.